Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802745
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-07
First Post:
2023-03-25
Brief Title:
P01 and Extubation Failure in Critically Ill Patients
Sponsor:
Cleveland Clinic Abu Dhabi
Organization:
Cleveland Clinic Abu Dhabi
Study Overview
Official Title:
Airway Occlusion Pressure P01 to Predict Extubation Failure in Critically Ill Patients A Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation MV is no longer required Extubation failure EF occurs in approximately 10-30 12 of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial SBT EF is associated with prolonged MV as well as increased morbidity and mortality 2 Therefore the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes
EF can result from different factors respiratory metabolic neuromuscular particularly cardiac factor and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load 13
Respiratory drive represents the intensity of the neural stimulus to breathe In mechanically ventilated patients it can be abnormally low ie suppressed or insufficient or abnormally high ie excessive and thus result in excessively low or high inspiratory effort leading to potential injury to the respiratory muscles ie myotrauma 45 or to the lungs A high incidence of abnormal drive low or high may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation 6
Airway occlusion pressure P01 is the drop in airway pressure Paw 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway 7 P01 measurement is not perceived by the patient and does not influence respiratory pattern It is in theory a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patients response to the occlusion and it is independent of respiratory mechanics 8 P01 has also been correlated with inspiratory effort 9 10 and it has been shown that in patients under assisted mechanical ventilation P01 might be able to detect potentially excessive inspiratory effort 11
P01 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it Originally a high P01 during a spontaneous breathing trial was associated with failure suggesting that a high respiratory drive could predict weaning failure However only a few and old clinical studies investigated the association between P01 and extubation failure EF and were not conclusive 1213 We hypothesized that patients with EF would have increased P01 values during spontaneous breathing trial SBT Therefore the aims of our study will be to 1 to evaluate the ability of changes in P01 Delta-P01 during SBT to predict EF and 2 to assess if Delta-P01 is an independent predictor of EF
EF can result from different factors respiratory metabolic neuromuscular particularly cardiac factor and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load 13
Respiratory drive represents the intensity of the neural stimulus to breathe In mechanically ventilated patients it can be abnormally low ie suppressed or insufficient or abnormally high ie excessive and thus result in excessively low or high inspiratory effort leading to potential injury to the respiratory muscles ie myotrauma 45 or to the lungs A high incidence of abnormal drive low or high may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation 6
Airway occlusion pressure P01 is the drop in airway pressure Paw 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway 7 P01 measurement is not perceived by the patient and does not influence respiratory pattern It is in theory a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patients response to the occlusion and it is independent of respiratory mechanics 8 P01 has also been correlated with inspiratory effort 9 10 and it has been shown that in patients under assisted mechanical ventilation P01 might be able to detect potentially excessive inspiratory effort 11
P01 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it Originally a high P01 during a spontaneous breathing trial was associated with failure suggesting that a high respiratory drive could predict weaning failure However only a few and old clinical studies investigated the association between P01 and extubation failure EF and were not conclusive 1213 We hypothesized that patients with EF would have increased P01 values during spontaneous breathing trial SBT Therefore the aims of our study will be to 1 to evaluate the ability of changes in P01 Delta-P01 during SBT to predict EF and 2 to assess if Delta-P01 is an independent predictor of EF
Detailed Description:
Weaning protocol SBTs will be performed in semirecumbent patients on Pressure Support Ventilation PSV mode with inspiratory pressure of 5 cmH2O and positive-end-expiratory pressure PEEP of 5 cmH2O as per ICU protocol Inspiratory oxygen fraction FiO2 will be adjusted for the achievement of an arterial oxygen saturation value 90 as measured by pulse oximetry The SBT duration will be 30 minutes as per ICU protocol The criteria that will be used for poor SBT tolerance are 1 diaphoresis 2 use of accessory respiratory muscles 3 RR 35min 4 oxygen saturation by pulse oximetry 90 with FiO2 50 5 HR 140min or greater than a 20 increase from baseline 6 Systolic blood pressure 180 mmHg or 90 mmHg 7 development of cardiac arrhythmias andor low level of consciousness
The decision to stop SBT will be made by the physicians Patients who will fail SBT will be shifted to their previous ventilator mode and not be enrolled in the study
Patients who will complete the SBT will be extubated and followed-up for 72 hours The medical team physician nurse and respiratory therapist involved in the extubation decision will be blinded to the P01 results EF will be diagnosed if the patient is extubated but required reintubation within the following 72 hours Criteria for acute respiratory failure after extubation are the development of at least one of the following a respiratory acidosis with pH 732 and arterial CO2 pressure PaCO2 45 mmHg b arterial oxygen saturation 90 with FiO2 05 c RR 35min d clinical signs of respiratory fatigue
The management of post-extubation respiratory failure will not be protocolized and will be left to the physicians discretion
Ventilatory including P01 and hemodynamic parameters including EtCO2 will be recorded as the average of at least three measurements immediately before SBT during SBT and at 30 minutes after SBT initiation Arterial and central venous blood gas if central line present will be measured immediately before SBT and at 30 minutes after SBT initiation
The decision to stop SBT will be made by the physicians Patients who will fail SBT will be shifted to their previous ventilator mode and not be enrolled in the study
Patients who will complete the SBT will be extubated and followed-up for 72 hours The medical team physician nurse and respiratory therapist involved in the extubation decision will be blinded to the P01 results EF will be diagnosed if the patient is extubated but required reintubation within the following 72 hours Criteria for acute respiratory failure after extubation are the development of at least one of the following a respiratory acidosis with pH 732 and arterial CO2 pressure PaCO2 45 mmHg b arterial oxygen saturation 90 with FiO2 05 c RR 35min d clinical signs of respiratory fatigue
The management of post-extubation respiratory failure will not be protocolized and will be left to the physicians discretion
Ventilatory including P01 and hemodynamic parameters including EtCO2 will be recorded as the average of at least three measurements immediately before SBT during SBT and at 30 minutes after SBT initiation Arterial and central venous blood gas if central line present will be measured immediately before SBT and at 30 minutes after SBT initiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None